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Tentative Approval Granted for Risperidone Tablets
April 5, 2004
PITTSBURGH--(BUSINESS WIRE)--April 5, 2004--Mylan Laboratories Inc. (NYSE: MYL) today announced that the U.S. Food and Drug Administration (FDA) has granted tentative approval for Mylan Pharmaceuticals Inc.'s Abbreviated New Drug Application for Risperidone Tablets in 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg strengths. Risperidone is the generic version of Janssen Pharmaceutica's Risperdal(R) Tablets.
Risperidone is one of ten potential first-to-file opportunities for Mylan currently before the FDA.
Source: Mylan Laboratories Inc.
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